Analyte Monitoring Devices

ABSTRACT

Covers for covering an opening in an analyte meter, and meters that include the same are provided.

BACKGROUND OF THE INVENTION

Analytical sensors are commonly used to monitor the level of an analytein a body fluid. For example, diabetics use analyte sensors to monitorbody glucose levels.

Analyte testing may involve testing once per day, but typically shouldbe carried out periodically throughout the day using multiple analytesensors—one sensor for each test. To “read” a sensor, i.e., to analyzethe body fluid applied to a sensor and determine one or more analytelevels, a sensor reader, oftentimes referred to as a “meter”, is used.Either before or after a sample of body fluid is applied to a sensor,the sensor is received by a meter. The meter performs various functionsand analyzes the sensor-applied sample to provide an analyte level tothe user.

The sensor receiving area of a meter, commonly referred to as a sensor“port”, is the opening in a meter that receives a sensor for testing.The sensor port is therefore an opening from the outside meterenvironment to the interior of the meter. Because the interior isexposed to the outside environment via the sensor port, the potentialfor contaminating materials to enter the meter's interior through theport exists. Such contamination may interfere with the readings and foulthe analyte results. Given the importance of obtaining accurate analytelevel readings, it is imperative that the meter does not becomecontaminated.

Accordingly, as meters continue to be used for analyte monitoring, therecontinues to be an interest in analyte monitoring devices that are notopen to contamination, e.g., when a sensor is absent from the sensorreceiving area of the device.

SUMMARY OF THE INVENTION

Analyte testing medical devices, and components for use with the same,as well as methods of using the medical devices and components foranalyte testing are provided.

Various embodiments include a cover for covering a sensor receiving portof a meter. The cover may be positioned about the meter port to provideclosure thereof, and capable of being moved to a testing potion in whichthe port is opened so that a sensor may be received by the meter. Incertain embodiments, a cover is fixedly secured at a first end to themeter, and cooperates with the meter at a second end to close themeter's port, but thereby permit rotation of the cover relative to themeter about the fixedly secured end (e.g., about a pivot point), but tosubstantially prevent movement of the cover relative to the meter otherthan to open the port for sensor access, e.g., to substantially preventmovement of the cover relative to the meter other than rotation about apivot point at the fixed end. Accordingly, various embodiments arespring biased covers that self-close against a meter port. Embodimentsof the self-closing covers may open and lock in an open position by wayof a locking mechanism.

In certain embodiments, a cover is adapted to be moveable from a closedstate (e.g., a biased closed state) to an open state (a testingposition) by the action of inserting a sensor into the port. Embodimentsinclude covers that may open a meter port and guide a sensor into theport in a single action.

Also provided are analyte meters that include the subject port covers,and systems and kits that include one or more of an analyte meter, portcover, analyte sensor, and lancing device.

These and various other features which characterize the invention arepointed out with particularity in the attached claims. For a betterunderstanding of the sensors of the invention, their advantages, theiruse and objectives obtained by their use, reference should be made tothe drawings and to the accompanying description, in which there isillustrated and described preferred embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

Referring now to the drawings, wherein like reference numerals andletters indicate corresponding structure throughout the several views:

FIG. 1A shows a side view of an exemplary embodiment of a port cover ina closed position covering a sensor port of a meter, and sensorpositioned to be received in the port;

FIG. 1B shows a side view of the port cover of FIG. 1A in a closedposition with a sensor positioned to be received in the port; and

FIG. 1C shows the cover of FIGS. 1A and 1B in the open or testingposition providing sensor access to the port.

DETAILED DESCRIPTION

As summarized above, covers for protecting a sensor opening or port ofan analyte monitoring device are provided. The covers are particularlyuseful in providing openable doors to the interiors of meters to protectthe interiors from contaminants that may enter the meters through thesensor ports. Accordingly, the meter doors are configured tosubstantially seal a sensor opening of a meter so that contaminants areexcluded from the port. In certain embodiments, the port may be includedin, e.g., integrated, a continuous analyte monitoring system.

The covers may be adapted to be used with any medical device having anopening and are particularly useful as adapted to be used with ananalyte monitoring medical device having an opening for receiving asensor (also commonly referred to as a test strip), such as an in vitroanalyte monitoring meter or in vivo analyte monitoring system, e.g.,those provided by Abbott Diabetes Care Inc. of Alameda, Calif. Metersmay be electrochemical or optical meters, and may be configured todetermine the level of one or more analytes, where analytes include, butare not limited to, glucose, lactate, acetyl choline, amylase,bilirubin, cholesterol, chorionic gonadotropin, creatine kinase (e.g.,CK-MB), creatine, DNA, fructosamine, glucose, glutamine, growthhormones, hormones, ketones, lactate, peroxide, prostate-specificantigen, prothrombin, RNA, thyroid stimulating hormone, and troponin, insample of body fluid. Meters may also be configured to determine theconcentration of drugs, such as, for example, antibiotics (e.g.,gentamicin, vancomycin, and the like), digitoxin, digoxin, drugs ofabuse, theophylline, and warfarin, may also be determined and the like,in a sample of body fluid. In certain embodiments, the covers are shapedand sized to cooperate with a FreeStyle® blood glucose monitoring meteror a Precision® brand blood monitoring meter capable of monitoringglucose and ketones. In certain embodiments, the covers may beconfigured to close a port of a continuous analyte monitoring system.For example, a continuous glucose monitoring system may include acomponent that receives analyte data from a transcutaneously insertedglucose sensor (a “receiver”), and which component may be configured tocommunicate analyte results to the user, e.g., audibly by way of adisplay, or visually. The continuous monitoring system receiver mayinclude a conventional blood glucose meter and therefore a port foraccepting a glucose test strip. The conventional meter and test stripmay be used to calibrate the continuous system (see for example U.S.Pat. No. 6,175,752). It is to be understood that description of coversfor opening of meters includes stand-alone meters, as well thoseoperably connected to, e.g., integrated with, continuous analytemonitoring systems. Exemplary sensors and meters and continuous analytemonitoring systems (sometimes referred to a in vivo system) that may beemployed include sensors and meters such as those described, e.g., inU.S. Pat. Nos. 6,071,391; 6,120,676; 6,143,164; 6,299,757; 6,338,790;6,377,894; 6,600,997; 6,773,671; 6,514,460; 6,592,745; 5,628,890;5,820,551; 6,736,957; 4,545,382; 4,711,245; 5,509,410; 6,540,891;6,730,200; 6,764,581; 6,299,757; 6,338,790; 6,461,496; 6,503,381;6,591,125; 6,616,819; 6,618,934; 6,676,816; 6,749,740; 6,893,545;6,942,518; 6,175,752; and 6,514,718, and elsewhere.

The covers may be fixedly attached/attachable to a meter, or may bewholly removable from a meter. For example, a cover may be configured tobe attachable to a meter over the port, but yet easily removable by auser when access to the sensor port is desired. In such cases, a covermay be removably attached about a sensor port of a meter in any suitablemanner, e.g., snap fit, friction fit, hook and loop engagement (e.g.,Velcro), or other chemical or physical bonding method. Alternativesinclude adhesive bonding, solvent welding, molded-in snap fit joints andthe use of fasteners such as screws. For example, certain embodimentssnap fit a soft material cover to hard plastic features (holes or slots)or injection mold into it.

In certain embodiments, a portion of a cover is attached to the meter,allowing an unattached portion to move away from the meter to expose theport. For example, a cover may be fixedly secured at its first end to ameter, and may cooperate with the meter at a second end to close theport about which the cover is positioned, yet permit movement of thecover in a direction to open the port, e.g., generally downward, upward,sideways, depending on its relation to the housing to provide access tothe interior of the meter. A cover may be fixed at a portion thereof tothe meter to enable rotation of the cover relative to the meter about apivot point, e.g., about at least one hinge or spring biased hingemechanism, but to substantially prevent movement of the cover relativeto the meter other than rotation about the at least one pivot point. Forexample, in certain embodiments the cover is attached to the meter,e.g., at the bottom of the meter, and may be opened like a flap toexpose the sensor port.

The cover may be biased in a first or closed position to cover a sensorport. In certain embodiments, a spring may bias the closeable cover in apredetermined position, for example the closed position shown in FIG.1A. The biasing force, e.g., provided by a spring, causes the cover toswing back to its initial starting position when the force causing theinitial displacement is removed, e.g., a sensor is removed from theport. By way of example, a user may open a cover by pushing or pullingon the cover, thereby causing displacement from its original position.Alternatively, insertion of a sensor into the port may provide a forcesufficient to open the cover, e.g., in a single action. A sensorreceived in the port may maintain the cover in an open position or thecover may lock in an open position. Once the displacement force isremoved, e.g., a sensor is removed from the port such as after analytetesting, the cover is urged back to its starting position to close theport.

In certain embodiments, a cover may also be configured to guide a sensorinto the port. For example, a cover may include guides, rails, channels,indentions, recessed structures, elevated structures, channels,orifices, clamps, and the like, e.g., on a sensor contacting surfacethereof. A cover may have two spaced apart guides extending from thecover. With this configuration, a sensor may be slid into a testedposition along the guides—the action thereof causing displacement of thecover in certain embodiments. The guides may be dimensioned such that asensor is snugly fit in the guides when it is mounted between theguides. During positioning of the sensor, portions of the sensor may begripped (such as with a user's fingers) and the gripped portions used tothen slide the sensor into the mounted position between the guides.

In certain embodiments, the covers may include a protrusion configuredto at least partially enter and reside in the sensor port when in theclosed position. This feature further ensures that contaminants will bekept out of the interior of the meter.

The covers may be made of any suitable material. In certain embodiments,the material is substantially flexible, but robust enough to withstandthe constant movement of the covers from the closed to open positions.Elastomeric materials may be used, e.g., rubber or other compliantmaterial. The covers may be treated or covered with a beneficial agent,e.g., antibacterial agent or the like.

The covers may be attached to the meter during manufacture, e.g., inthose embodiments in which a cover is fixedly attached to a meter atleast at one portion of the cover. Alternatively, a cover may beprovided to users detached from a meter, but easily attachable by auser. In such instances, covers may be re-usable.

Referring now to the Figures, FIG. 1A shows an analyte meter 10 having asensor port 12. Meter 10 includes housing 12 defining an interior spaceand having a sensor port 14 that is closed by sensor port cover 20. Inthis particular embodiment, cover 20 has a substantially C-shaped body,such that the “C” is adapted to cooperate with a portion of the meterand in particular a portion of the sensor port. Cover protrusion 26intrudes into port 14. In this embodiment, the “C” is configured tocooperate and fit with the “bottom” of the port in a matingrelationship. It will be appreciated that throughout the presentapplication, words such as “top”, “bottom”, “upper”, and “lower”, andthe like, are used in a relative sense only.

FIG. 1B shows an analyte sensor 30, e.g., a glucose sensor, beingpositioned against cover 20 for insertion into port 14. The sensor isshown as having a generally rectangular shape, but it is to beappreciated that any shaped sensor may be used. As best seen in FIG. 1B,the bottom of the “C” or first cover end 22 is pivotally attached to themeter and the top of the “C” or second cover end 24 is not fixedlyattached to the meter so that it may pivot downward as shown in FIGS. 1Band 1C. Sensor 30 is guided down a shoulder of the cover to operativelyposition the sensor in the sensor port. In this embodiment, the actionof inserting sensor 30 into port 14 opens cover 20 to permit access tothe port. This single action sensor insertion/cover opening minimizesthe steps required to open the port and insert the sensor into themeter. FIG. 1C shows the cover in a fully displaced position and sensor30 operatively positioned in port 14 for testing. Once the sensor isremoved, the cover may spring back to its closed position or may bemanually pushed back into position depending on the particularembodiment. When a sensor is inserted into port, a part of the cover maycontact at least a bottom (cover contacting side) and/or the sides ofthe sensor, to prevent sample from moving into the port along the sensorbottom side and/or one or more sensor sides. Pressure may be applied toa surface of the sensor from the cover when it is in the open positionto provide a tighter cover/sensor interface.

A sample of biological fluid is provided to the sensor for analytetesting, where the level of analyte is determined. In many embodiments,it is the level of glucose in blood, interstitial fluid, and the like,that is determined. Also in many embodiments, the source of thebiological fluid is a drop of blood drawn from a patient, e.g., afterpiercing the patient's skin with a lancing device or the like.

Embodiments of the subject methods may include contacting the sensor,either before or after opening the door to the sensor port, andtransferring a volume of fluid from a skin incision to the sensor.

In any event, before, during or after sample is contacted with thesample chamber, the sensor is coupled to a meter and the concentrationof an analyte in the sample, e.g., glucose, is determined.

The invention has been described with reference to various specific andpreferred embodiments and techniques. However, it will be apparent toone of ordinarily skill in the art that many variations andmodifications may be made while remaining within the spirit and scope ofthe invention.

All patents and other references in this specification are indicative ofthe level of ordinary skill in the art to which this invention pertains.All patents and patent applications are herein incorporated by referenceto the same extent as if each individual patent was specifically andindividually incorporated by reference.

1. A meter for determining the concentration of an analyte, the metercomprising: a housing with an opening for receiving an analyte sensor;and a cover configured to close the opening when a sensor is notreceived in the meter and to expose the opening to receive a sensor inthe meter.
 2. The meter of claim 1, wherein the cover is moveable from afirst position wherein the cover closes the opening to a second positionthat provides sensor access to the opening.
 3. The meter of claim 1,wherein the second position is provided by moving a portion of the coveraway from the housing while another portion of the cover remainsattached to the housing.
 4. The meter of claim 3, wherein the attachedportion is fixedly attached to the housing.
 5. The meter of claim 4,wherein the attached portion is pivotally attached to the housing. 6.The meter of claim 1, wherein the cover contacts a sensor received inthe meter.
 7. The meter of claim 6, wherein the cover provides pressureagainst a sensor received in the meter.
 8. The meter of claim 1, whereinthe cover does not provide substantial pressure against a sensorreceived in the meter.
 9. The meter of claim 1, wherein the cover iscomprised of a soft material.
 10. The meter of claim 1, wherein thecover is comprised of an elastomeric material.
 11. The meter of claim 1,wherein the cover is openable by the insertion of a sensor into themeter.
 12. The meter of claim 1, wherein the meter is an electrochemicalmeter.
 13. The meter of claim 1, wherein the meter is an optical meter.14. A cover for covering a sensor opening in a meter, the covercomprising: a first part attachable to an analyte meter; and a secondpart detachable from the analyte meter to provide sensor access to thesensor opening of the meter.
 15. The cover of claim 14, wherein thefirst part is configured to pivot about an area of a meter.
 16. Thecover of claim 14, wherein the cover includes a protruding portionconfigured to protrude a distance into the sensor opening of a meter.17. The cover of claim 14, wherein the cover is positionable about ameter so that the second part cooperates with the meter when in a closedposition to provide a seal about the sensor opening of the meter. 18.The cover of claim 17, wherein the cover is positionable about a meterso that the second part is moved away from the meter in an open positionto provide sensor access to the opening of the meter.
 19. The cover ofclaim 18, wherein the cover is biased to the closed position.
 20. Thecover of claim 18, wherein opening of the cover and inserting a sensorinto the meter may be accomplished in a single action.
 21. The cover ofclaim 20, wherein the cover is configured to guide a sensor into thesensor opening of a meter and open the cover in the same action.
 22. Thecover of claim 17, wherein the cover is self closing.
 23. A continuousglucose monitoring system for determining the concentration of glucose,the system comprising: a glucose test strip port configured to receive atest strip; and a cover configured to close the port when a test stripis not received in the port and to expose the port to receive a teststrip.
 24. The system of claim 23, wherein the cover is moveable from afirst position wherein the cover closes the port to a second positionthat provides test strip access to the port.
 25. The system of claim 23,wherein the second position is provided by moving a portion of the coveraway from the port while another portion of the cover remains attached.26. The system of claim 25, wherein the attached portion is fixedlyattached.
 27. The system of claim 26, wherein the attached portion ispivotally attached.
 28. The system of claim 23, wherein the covercontacts a test strip received in the port.
 29. The system of claim 28,wherein the cover provides pressure against a test strip received in theport.
 30. The system of claim 23, wherein the cover does not providepressure against a test strip received in the port.